83. 支持抗淀粉样蛋白单克隆抗体治疗美国退伍军人早期阿尔茨海默病的安全性

IF 3.8 2区 医学 Q1 GERIATRICS & GERONTOLOGY
Alexandra Fortunato , Alison O'Donnell , Brittany Spitznogle , Naveen Reddy , Shaye Kerper , Steven Handler
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引用次数: 0

摘要

与普通人群相比,由于军事和非军事相关的风险因素,美国退伍军人患痴呆症的风险增加。随着美国食品和药物管理局(FDA)批准lecanemab (Leqembi®),一种针对淀粉样蛋白β的单克隆抗体疗法(mAb),退伍军人现在可以获得阿尔茨海默病(AD)的疾病改善治疗。这种新疗法在退伍军人管理局的实施暴露了重大的教育差距和安全挑战。具体来说,缺乏退伍军人和面向临床医生的材料来实施和监测lecanemab。因此,从2024年1月4日到2024年8月9日,这个项目的作者开发了各种各样的材料,并通过VA国家SharePoint网站发布。面向退伍军人的材料优先考虑了教育和安全,并包括了关于lecanemab及其潜在不良影响的信息。还开发了一种钱包卡,以强调如果发生某些副作用,需要进行紧急评估和核磁共振脑部扫描。面向临床医生的文献主要集中在莱卡耐单抗的潜在不良反应、退伍军人纳入/排除标准以及AD的诊断。为了更好地了解这些新材料在国家层面上的影响,我们开发并分发了一项调查,以选择退伍军人管理局的医疗保健专业人员。该项目的目的是进行差距分析,获得关于目前可用的莱卡耐单抗教育材料的广泛反馈,并确定开发和传播其他材料的优先顺序,以支持在va内安全使用莱卡耐单抗。方法我们对积极参与国家退伍军人健康管理局(VHA)新型阿尔斯海默病治疗实践社区(CoP)工作组的医疗保健专业人员进行了横断面调查。该调查于2024年9月17日发出,一直开放到2024年10月4日。如上文所述,主要结果是CoP工作组中参与lecanemab实施的医疗保健专业人员对现有的lecanemab教育材料的认识。自第二个单抗以来,只有lecanemab进行了评估,donanemab (Kisunla®)在研究时尚未上市。次要结果侧重于评估必要资源的有效性,以确定有资格使用lecanemab的退伍军人,教育退伍军人和护理人员使用该药物,确定适当的给药计划,建立监测方案,并有效管理潜在的副作用。结果是用微软的基于网络的调查软件进行测量的,并以5分的李克特量表进行报告,范围从“非常不同意”到“非常同意”。两个积极的反应(“同意”和“非常同意”)和两个消极的反应(“不同意”和“非常不同意”)分别组成积极和消极的反应组。还征求了关于现有内部资源和需要额外资源的质量反馈。本研究被批准为质量改进项目。结果一次向128名卫生保健专业人员发送了一封包含调查链接的电子邮件,回复率为34% (n=44)。在应答者中,59%是医生(n=26), 25%是药剂师(n=11), 5%是心理学家(n=2), 5%是护士(n=2), 5%是项目经理(n=2), 2%拒绝提供他们的角色(n=1)。总的来说,41% (n=18)表示他们目前正在使用莱卡耐单抗,32% (n=14)表示他们正在计划使用莱卡耐单抗,20% (n=9)表示他们不确定是否会使用莱卡耐单抗,7% (n=3)表示他们不会提供这种药物。43%的参与者(n=19)表示他们不知道关于lecanemab的现有教育材料。在对lecanemab的了解方面,77% (n=34)的人表示他们有必要的资源来决定lecanemab是否适合患者,73% (n=32)的人认为他们有资源来确定合适的给药计划,64% (n=28)的人认为他们有资源来确定监测要求,64% (n=28)的人认为他们有资源来识别和指导副作用管理。结论:我们的结果表明,CoP工作组内的医疗保健专业人员(其中许多人在各自的站点参与了lecanemab的实施)并不了解现有的文件。此外,这些结果确定了可用资源有效性方面的差距。本次调查的反馈将有助于指导进一步开发和传播有关lecanemab和其他单抗的实施、处方和监测的教育材料,最终提高退伍军人护理的质量和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
83. SUPPORTING THE SAFETY OF ANTI-AMYLOID MONOCLONAL ANTIBODY THERAPY FOR EARLY ALZHEIMER'S DISEASE IN UNITED STATES VETERANS

Introduction

Aging United States Military Veterans are at an increased risk of developing dementia compared to the general population due to both military and non-military-related risk factors. With the Food and Drug Administration (FDA) approval of lecanemab (Leqembi ®), a monoclonal antibody therapy (mAb) directed against amyloid beta, Veterans now have access to disease modifying treatment for Alzheimer’s Disease (AD). The implementation of this novel treatment at the VA has uncovered significant education gaps and safety challenges. Specifically, there was a lack of both Veteran and clinician-facing materials for implementation and monitoring lecanemab. Thus, a variety of materials were developed by this project's authors from January 4, 2024 through August 9, 2024 and were distributed via the national VA SharePoint site. Veteran-facing materials prioritized education and safety and included information about lecanemab and its potential adverse effects. A wallet card was also developed to highlight the need for emergent evaluation and MRI brain scan if certain side effects occurred. Clinician-facing documents focused on the potential adverse effects of lecanemab, Veteran inclusion/exclusion criteria, and diagnosis of AD. To better understand the impact that these new materials have had at a national level, we developed and distributed a survey to select VA healthcare professionals. The objective of this project was to perform a gap analysis, obtain broad feedback on currently available educational materials for lecanemab, and set priorities for the development and dissemination of additional materials to support the safe use of lecanemab within the VA.

Methods

We conducted a cross-sectional survey of healthcare professionals who actively participate in the national Veteran’s Health Administration (VHA) Novel AD Therapeutics Community of Practice (CoP) Workgroup. The survey was sent out on September 17, 2024 and remained open until October 4, 2024. The primary outcome was the awareness of existing lecanemab educational materials, as described above, among healthcare professionals in the CoP Workgroup involved in lecanemab implementation. Only lecanemab was evaluated since the second mAb, donanemab (Kisunla®) was not commercially available at the time of the study. Secondary outcomes focused on evaluating the effectiveness of resources necessary to: identify Veterans eligible for lecanemab, educate Veterans and caregivers on its use, determine the appropriate dosing schedule, establish monitoring protocols, and manage potential side effects effectively. Outcomes were measured using Microsoft Forms web-based survey software and were reported on a 5-point Likert scale, ranging from “strongly disagree” to “strongly agree”. The two positive responses (“agree” and “strongly agree”) and the two negative responses (“disagree” and “strongly disagree”) were combined to make positive and negative response groups, respectively. Qualitative feedback was also solicited about existing internal resources and the need for additional resources. This study was approved as a quality improvement project.

Results

An email containing a link to the survey was sent one time to 128 healthcare professionals with a 34% response rate (n=44). Of the responders, 59% were physicians (n=26), 25% were pharmacists (n=11), 5% were psychologists (n=2), 5% were nurses (n=2), 5% were program managers (n=2), and 2% declined to provide their role (n=1). In all, 41% (n=18) indicated that they were currently administering lecanemab, 32% (n=14) indicated that they were planning on administering lecanemab, 20% (n=9) indicated that they were unsure if they would be administering lecanemab, and 7% (n=3) indicated that they would not be offering the medication.
Forty-three percent of participants (n=19) indicated that they were unaware of existing educational materials about lecanemab. In terms of knowledge of lecanemab, 77% (n=34) indicated that they had the necessary resources to decide if lecanemab is right for a patient, 73% (n=32) felt they had the resources to determine the appropriate dosing schedule, 64% (n=28) felt they had the resources to determine monitoring requirements, and 64% (n=28) felt they had the resources to identify and guide management of side effects.

Conclusions

Our results demonstrate that healthcare professionals within the CoP Workgroup, many of whom have been involved in lecanemab implementation at their respective sites, were not aware of existing documents. Furthermore, these results identify a gap regarding effectiveness of available resources. Feedback from this survey will help guide further development and dissemination of educational materials regarding implementation, prescribing, and monitoring of lecanemab and other mAb as they become available, ultimately improving the quality and safety of Veteran care.
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来源期刊
CiteScore
13.00
自引率
4.20%
发文量
381
审稿时长
26 days
期刊介绍: The American Journal of Geriatric Psychiatry is the leading source of information in the rapidly evolving field of geriatric psychiatry. This esteemed journal features peer-reviewed articles covering topics such as the diagnosis and classification of psychiatric disorders in older adults, epidemiological and biological correlates of mental health in the elderly, and psychopharmacology and other somatic treatments. Published twelve times a year, the journal serves as an authoritative resource for professionals in the field.
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